Cellular Biomedicine Group Reports Second Quarter and First Half 2017 Financial Results and Business Highlights
August 08 2017 - 4:31PM
Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), a clinical-stage biopharmaceutical firm engaged in the
development of effective immunotherapies for cancer and stem cell
therapies for degenerative diseases, today reported financial
results and business highlights for the second quarter and six
months ended June 30, 2017.
“In the first half of 2017, we made significant
advancements in our dual technology platforms of immuno-oncology
and stem cells,” commented Tony (Bizuo) Liu, CBMG’s Chief Executive
Officer. “In China we successfully launched two Phase I
clinical trials for our anti-CD19 CAR-T product C-CAR011 and we
expect to report topline clinical data from both trials by
year-end. In the United States the development of AlloJoinTM, our
“off-the-shelf” allogeneic adipose stem cell candidate, continues
to progress with the recent $2.29 million award from California
Institute for Regenerative Medicine (CIRM) to establish a cell line
and IND filing in the treatment of Knee Osteoarthritis (KOA).” Mr.
Liu further stated, “Upon completion of our new Shanghai GMP
facility later this year, we believe we will have one of the
largest cell therapy facilities in the world. The Shanghai facility
will house our joint technology laboratory with GE Healthcare Life
Sciences China to co-develop high-quality industrial control
processes in CAR-T and stem cell manufacturing. With these recent
advancements in our pipelines and validation of our GMP
capabilities, we believe we will have the first mover advantage to
deliver effective cell therapies in China. The recent unanimous
U.S. FDA Advisory Committee approval of a large pharma’s Biological
License Application (BLA) designated as Breakthrough Therapy on a
CAR-T candidate for the treatment of relapsed/refractory B-cell
acute lymphoblastic leukemia (ALL), and the FDA acceptance of
another company’s diffuse large B-cell lymphoma (DLBCL) BLA filing
under Priority Review, have set a precedent for a substantially
shortened review clock for such breakthrough therapies in the
United States. With both ALL and DLBCL in our pipeline, we are
hopeful to see an analogous accelerated BLA review treatment in
China when we are ready for our submission.”
Second Quarter and First Half 2017 Financial
Performance
- Cash Position: Cash and cash equivalents as of
June 30, 2017 were $27.3 million compared to $39.3 million as of
December 31, 2016.
- Net Cash Used in Operating Activities: Net
cash used in operating activities for the quarter and six months
ended June 30, 2017 was $2.9 million and $7.8 million (offset by
$1.2 million CIRM grant in Q2), respectively, compared to $5.2
million and $8.8 million for the same periods in 2016.
- G&A Expenses: General and
administrative expenses for the quarter and six months ended June
30, 2017 were $3.3 million and $6.5 million, respectively, compared
to $3.1 million and $5.8 million for the same periods in 2016.
- R&D Expenses: Research and
development expenses for the quarter and six months ended June 30,
2017 were $3.3 million and $6.4 million respectively, compared to
$3.0 million and $5.4 million for the same periods in 2016.
- Net Loss: Net loss allocable to common stock
holders for the quarter and six months ended June 30, 2017 was $6.2
million and $12.4 million respectively, compared to $7.2 million
and $11.4 million for the same periods in 2016.
Recent Business Highlights First Half 2017
- Appointment of Michael A. Caligiuri, MD, current President of
American Association for Cancer Research (AACR), as Chair of the
External Advisory Board;
- Signed a strategic research collaboration agreement with GE
Healthcare Life Sciences China to establish a joint technology
laboratory in CBMG’s new Shanghai Zhangjiang GMP facility in order
to co-develop control processes for the manufacture of CAR-T and
stem cell therapies;
- Completed expansion of our 30,000 square foot facility in
Huishan High Tech Park in Wuxi, China;
- Signed a ten-year lease of a 113,038 square feet building
located in the “Pharma Valley” in Shanghai Zhangjiang High-Tech
Park. The new GMP facility that will be built on these premises
will consist of 40,000 square feet dedicated to advanced cell
manufacturing.
Clinical Developments First Half 2017
Immuno-Oncology Platform
- Commenced Phase I Trial (CALL-1) for C-CAR011 in adult patients
with r/r B-cell ALL in China;
- Commenced patient enrollment in a new independent Phase I
clinical trial of the Company’s ongoing CARD-1 study in patients
with chemorefractory and aggressive DLBCL;
- Publication of an abstract exploring the application of B-cell
antigen, CD20, for targeted Chimeric Antigen Receptor T
cells (CAR-T) therapy, in conjunction with the 2017 American
Society of Clinical Oncology (ASCO) Annual Meeting.
Stem Cell Platform
- Awarded $2.29 million by California Institute for Regenerative
Medicine (CIRM), California’s stem cell agency, to support
pre-clinical studies of AlloJoinTM, CBMG’s “off-the-shelf”
allogeneic human adipose-derived mesenchymal stem cells (haMPC) for
the treatment of KOA in the United States.
About Cellular Biomedicine GroupCellular
Biomedicine Group, Inc. (NASDAQ:CBMG) develops proprietary cell
therapies for the treatment of cancer and degenerative diseases. We
conduct immuno-oncology and stem cell clinical trials in China
using products from our integrated GMP laboratory. Our GMP
facilities in China, consisting of twelve independent cell
production lines, are designed and managed according to both China
and U.S. GMP standards. To learn more about CBMG, please visit
www.cellbiomedgroup.com.
Forward-Looking Statements Statements in this
press release relating to plans, strategies, trends, specific
activities or investments, and other statements that are not
descriptions of historical facts may be forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995, Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking information is inherently subject to risks and
uncertainties, and actual results could differ materially from
those currently anticipated due to a number of factors, which
include risks inherent in doing business, trends affecting the
global economy, including the devaluation of the RMB by China in
August 2015 and other risks detailed from time to time in CBMG’s
reports filed with the Securities and Exchange Commission,
quarterly reports on form 10-Q, current reports on form 8-K and
annual reports on form 10-K. Forward-looking statements may be
identified by terms such as "may," "will," "expects," "plans,"
"intends," "estimates," "potential," or "continue," or similar
terms or the negative of these terms. Although CBMG believes the
expectations reflected in the forward-looking statements are
reasonable, they cannot guarantee that future results, levels of
activity, performance or achievements will be obtained. CBMG does
not have any obligation to update these forward-looking statements
other than as required by law.
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
AND COMPREHENSIVE LOSS |
(UNAUDITED) |
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
For the Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
Net sales and
revenue |
|
$62,914 |
|
|
$71,599 |
|
|
$161,339 |
|
|
$560,090 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
38,097 |
|
|
|
323,587 |
|
|
|
75,499 |
|
|
|
826,780 |
|
General
and administrative |
|
|
3,319,093 |
|
|
|
3,072,647 |
|
|
|
6,504,340 |
|
|
|
5,848,572 |
|
Selling
and marketing |
|
|
76,385 |
|
|
|
39,480 |
|
|
|
194,269 |
|
|
|
218,234 |
|
Research
and development |
|
|
3,349,509 |
|
|
|
2,972,855 |
|
|
|
6,393,634 |
|
|
|
5,371,217 |
|
Total
operating expenses |
|
|
6,783,084 |
|
|
|
6,408,569 |
|
|
|
13,167,742 |
|
|
|
12,264,803 |
|
Operating loss |
|
|
(6,720,170 |
) |
|
|
(6,336,970 |
) |
|
|
(13,006,403 |
) |
|
|
(11,704,713 |
) |
|
|
|
|
|
|
|
|
|
Other income: |
|
|
|
|
|
|
|
|
Interest
income |
|
|
40,573 |
|
|
|
18,290 |
|
|
|
89,755 |
|
|
|
35,340 |
|
Other
income |
|
|
476,079 |
|
|
|
7,646 |
|
|
|
553,587 |
|
|
|
23,966 |
|
Total
other income |
|
|
516,652 |
|
|
|
25,936 |
|
|
|
643,342 |
|
|
|
59,306 |
|
Loss before taxes |
|
|
(6,203,518 |
) |
|
|
(6,311,034 |
) |
|
|
(12,363,061 |
) |
|
|
(11,645,407 |
) |
|
|
|
|
|
|
|
|
|
Income taxes credit
(provision) |
|
|
- |
|
|
|
(886,248 |
) |
|
|
(2,450 |
) |
|
|
238,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$(6,203,518 |
) |
|
$(7,197,282 |
) |
|
$(12,365,511 |
) |
|
$(11,407,395 |
) |
Other comprehensive
income (loss): |
|
|
|
|
|
|
|
|
Cumulative translation adjustment |
|
|
292,452 |
|
|
|
(271,438 |
) |
|
|
346,121 |
|
|
|
(255,365 |
) |
Unrealized gain (loss) on investments, net of tax |
|
|
(240,000 |
) |
|
|
(11,115,884 |
) |
|
|
(240,000 |
) |
|
|
5,300,633 |
|
Total
other comprehensive income (loss): |
|
|
52,452 |
|
|
|
(11,387,322 |
) |
|
|
106,121 |
|
|
|
5,045,268 |
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$(6,151,066 |
) |
|
$(18,584,604 |
) |
|
$(12,259,390 |
) |
|
$(6,362,127 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share: |
|
|
|
|
|
|
|
|
Basic |
|
$(0.43 |
) |
|
$(0.52 |
) |
|
$(0.87 |
) |
|
$(0.89 |
) |
Diluted |
|
$(0.43 |
) |
|
$(0.52 |
) |
|
$(0.87 |
) |
|
$(0.89 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
Basic |
|
|
14,298,973 |
|
|
|
13,737,722 |
|
|
|
14,211,888 |
|
|
|
12,810,894 |
|
Diluted |
|
|
14,298,973 |
|
|
|
13,737,722 |
|
|
|
14,211,888 |
|
|
|
12,810,894 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(UNAUDITED) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
Assets |
|
|
|
Cash and cash equivalents |
$27,298,445 |
|
|
$39,252,432 |
|
Accounts receivable, less allowance for doubtful amounts of
$10,407 |
|
|
|
and $10,163 as of June 30, 2017 and December 31, 2016,
respectively |
|
91,462 |
|
|
|
39,974 |
|
Other receivables |
|
1,014,721 |
|
|
|
412,727 |
|
Prepaid expenses |
|
995,128 |
|
|
|
986,951 |
|
Total current assets |
|
29,399,756 |
|
|
|
40,692,084 |
|
|
|
|
|
|
Investments |
|
269,424 |
|
|
|
509,424 |
|
Property, plant and equipment, net |
|
7,043,131 |
|
|
|
4,117,739 |
|
Goodwill |
|
7,678,789 |
|
|
|
7,678,789 |
|
Intangibles, net |
|
13,260,015 |
|
|
|
14,092,581 |
|
Long-term prepaid expenses and other assets |
|
2,226,327 |
|
|
|
1,537,850 |
|
Total assets |
$59,877,442 |
|
|
$68,628,467 |
|
|
|
|
|
|
Liabilities and Stockholders'
Equity |
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
Accounts payable |
$1,169,311 |
|
|
$216,154 |
|
Accrued expenses |
|
592,582 |
|
|
|
1,168,787 |
|
Taxes payable |
|
28,875 |
|
|
|
28,875 |
|
Deferred income |
|
1,069,515 |
|
|
|
- |
|
Other current liabilities |
|
1,660,093 |
|
|
|
950,220 |
|
Total current liabilities |
|
4,520,376 |
|
|
|
2,364,036 |
|
|
|
|
|
|
Other
non-current liabilities |
|
- |
|
|
|
370,477 |
|
Total liabilities |
|
4,520,376 |
|
|
|
2,734,513 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock, par value $.001, 50,000,000 shares |
|
|
|
authorized; none issued and outstanding as of |
|
|
|
June 30, 2017 and December 31, 2016, respectively |
|
- |
|
|
|
- |
|
|
|
|
|
|
Common stock, par value $.001, 300,000,000 shares
authorized; |
|
|
|
14,336,474 and 14,281,378 issued; and 14,166,305 and 14,281,378
outstanding, |
|
|
|
as of June 30, 2017 and December 31, 2016, respectively |
|
14,336 |
|
|
|
14,281 |
|
Treasury stock at cost; 170,169 and nil shares of common
stock |
|
|
|
as of June 30, 2017 and December 31, 2016, respectively |
|
(1,357,931 |
) |
|
|
- |
|
Additional paid in capital |
|
155,623,430 |
|
|
|
152,543,052 |
|
Accumulated deficit |
|
(97,912,198 |
) |
|
|
(85,546,687 |
) |
Accumulated other comprehensive income (loss) |
|
(1,010,571 |
) |
|
|
(1,116,692 |
) |
Total stockholders' equity |
|
55,357,066 |
|
|
|
65,893,954 |
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$59,877,442 |
|
|
$68,628,467 |
|
|
|
|
|
|
CELLULAR BIOMEDICINE GROUP, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
|
|
|
|
|
|
|
For the Six Months Ended |
|
|
June 30, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
Net
loss |
|
$(12,365,511 |
) |
|
$(11,407,395 |
) |
Adjustments to reconcile net loss to net cash |
|
|
|
|
used in
operating activities: |
|
|
|
|
Depreciation and amortization |
|
|
1,369,168 |
|
|
|
1,349,137 |
|
Gain on
disposal of assets |
|
|
(49 |
) |
|
|
- |
|
Stock
based compensation expense |
|
|
2,902,113 |
|
|
|
2,412,261 |
|
Inventory
provision |
|
|
- |
|
|
|
105,919 |
|
Allowance
for doubtful account |
|
|
- |
|
|
|
10,782 |
|
Changes
in operating assets and liabilities: |
|
|
|
|
Accounts
receivable |
|
|
(50,557 |
) |
|
|
275,333 |
|
Other
receivables |
|
|
(488,480 |
) |
|
|
20,521 |
|
Inventory |
|
|
- |
|
|
|
(25,309 |
) |
Prepaid
expenses |
|
|
13,246 |
|
|
|
(457,032 |
) |
Taxes
recoverable |
|
|
- |
|
|
|
150,082 |
|
Long-term
prepaid expenses and other assets |
|
|
(237,637 |
) |
|
|
(259,624 |
) |
Accounts
payable |
|
|
949,142 |
|
|
|
(124,531 |
) |
Accrued
expenses |
|
|
(595,382 |
) |
|
|
(387,695 |
) |
Deferred
income |
|
|
1,069,515 |
|
|
|
- |
|
Other
current liabilities |
|
|
35,542 |
|
|
|
(152,605 |
) |
Taxes
payable |
|
|
- |
|
|
|
30,000 |
|
Deferred
tax liabilities |
|
|
- |
|
|
|
(242,267 |
) |
Other
non-current liabilities |
|
|
(379,161 |
) |
|
|
(50,049 |
) |
Net cash
used in operating activities |
|
|
(7,778,051 |
) |
|
|
(8,752,472 |
) |
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
Proceeds
from disposal of assets |
|
|
286 |
|
|
|
- |
|
Purchases
of intangibles |
|
|
(23,339 |
) |
|
|
- |
|
Purchases
of assets |
|
|
(3,014,055 |
) |
|
|
(1,161,568 |
) |
Net cash
used in investing activities |
|
|
(3,037,108 |
) |
|
|
(1,161,568 |
) |
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
Net
proceeds from the issuance of common stock |
|
|
- |
|
|
|
42,437,374 |
|
Proceeds
from exercise of stock options |
|
|
73,779 |
|
|
|
175,399 |
|
Repurchase of treasury stock |
|
|
(1,357,931 |
) |
|
|
- |
|
Net cash
provided by financing activities |
|
|
(1,284,152 |
) |
|
|
42,612,773 |
|
|
|
|
|
|
EFFECT OF EXCHANGE RATE
CHANGES ON CASH |
|
|
145,324 |
|
|
|
(113,134 |
) |
|
|
|
|
|
INCREASE IN CASH AND
CASH EQUIVALENTS |
|
|
(11,953,987 |
) |
|
|
32,585,599 |
|
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD |
|
|
39,252,432 |
|
|
|
14,884,597 |
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD |
|
$27,298,445 |
|
|
$47,470,196 |
|
|
|
|
|
|
Contact:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
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